Comparison of 0.5% Tetracaine Drops Versus 2% Lidocaine Gel for Anesthetic Efficacy and Comfort in Patients Undergoing LASIK
试验速览
- 阶段
- 4 期
- 状态
- 终止
- 入组人数
- 11
- 试验地点
- 1
- 主要终点
- Participants Score on Pain Scale
研究概览
简要总结
In this study the investigators will be comparing two different types of anesthetic, a numbing eye drop and a numbing gel, to test if they are equally effective or if one has a better outcome in terms of the level of comfort you experience one hour and one day after your surgery. The two medications are commonly used and appear to be equally effective for other types of eye surgery, such as cataract surgery. This study will show if one type of anesthesia is preferred over another by patients getting LASIK. Before your LASIK procedure, you will be given a short questionnaire to determine the baseline comfort of your eyes. In the operating room, one type of anesthetic will be put in one eye, and the other medication will be put in the other eye. Which anesthetic you get in each eye will be chosen in a random way (similar to flipping a coin). After your LASIK surgery, the investigators will ask you if you felt more comfort in your right eye, your left eye, or if they were equal, and the investigators will ask you the same survey questions that were asked prior to your LASIK to get more details about your experience.
*Of note- the randomization being done is for which eye will be receiving the lidocaine and which eye will be receiving the tetracaine. Each patient will receive lidocaine in 1 eye and tetracaine in the other eye, the randomization is for each individual eye. This means, of 11 patients in our study, 22 eyes received treatment. 11 eyes received lidocaine and 11 eyes received tetracaine.
when we did our comparison, 11 values were used for lidocaine and 11 eyes were used for tetracaine, giving a total of 22 eyes. This is important to note since the randomization refers to EYE for each individual patient, and not for the patient (ie: participant means 1 eye, not 1 person in the descriptions below).
详细描述
Outcome measures involve comparing the right eye and left eye for severity of 12 different symptoms, that are recorded in severity on a 1-5 scale. A score of 1 means no symptoms and 5 means severe. The 12 measurements include sharp pain, dull ache, pain during movement, stinging sensation, itching, light sensitivity, watery eyes, dry eyes, sandy sensation, pressure sensation, decreased vision, and blurry vision.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Single Group
- 主要目的
- Supportive Care
- 盲法
- Double (Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •healthy volunteers of age 18 years or greater
排除标准
- •Previous reaction/allergy to the same drug class
- •prior ocular surgery
- •active facial injuries
- •any active current ophthalmological disease
- •history of diabetes
- •any current non- Over The Counter pain medication
- •inability to complete the questionnaire.
- •Economically or educationally disadvantaged persons, Prisoners, or Children
- •Patients with fluctuating or impaired decision-making capacity
- •Any other condition that the investigator believes would pose a significant hazard to the subject if the investigational therapy were initiated
研究组 & 干预措施
Tetracaine R/Lidocaine L
Participant's Right or Left eye will receive 0.5% Tetracaine drop, at 10 minutes and 5 minutes, prior to LASIK.
干预措施: Lidocaine gel (Drug)
Tetracaine R/Lidocaine L
Participant's Right or Left eye will receive 0.5% Tetracaine drop, at 10 minutes and 5 minutes, prior to LASIK.
干预措施: Tetracaine drop (Drug)
Tetracaine L/Lidocaine R
Participant's Right or Left eye will receive 2% lidocaine gel, at 10 minutes and 5 minutes, prior to LASIK.
干预措施: Tetracaine drop (Drug)
Tetracaine L/Lidocaine R
Participant's Right or Left eye will receive 2% lidocaine gel, at 10 minutes and 5 minutes, prior to LASIK.
干预措施: Lidocaine gel (Drug)
结局指标
主要结局
Participants Score on Pain Scale
时间窗: 1 hour (60minutes) post LASIK operation
Do you have sharp pain in your eye? Pain will be assessed by units on a scale of 1-5: 1 means no symptoms, 2 means slight discomfort, 3 means mild discomfort, 4 means moderate discomfort, and 5 means severe discomfort
次要结局
未报告次要终点